Due to the growing awareness of medical complications associated with the use of oral contraceptives and intra-uterine devices, interest in other contraceptive methods has increased. Other contraceptive methods presently in use include diaphragms, sponges, cervical caps, spermicidal creams, foams, and suppositories for women, and condoms for men. Diaphragms and cervical caps usually require fitting by trained medical personnel, and must be refitted or replaced on a regular basis. Sponges take up a relatively large volume, which may result in a feeling of discomfort. Chemical barrier contraceptives such as creams, foams, jellies, tablets, and suppositories are often inconvenient and messy to apply and use, and in some cases cause irritation. Condoms are considered inconvenient to use during sexual activity and interfere with the sensation of the users. Thus, all such contraceptive methods in current use cause some inconvenience to users and detract from the users' spontaneity or feeling of pleasure during sexual activity.
Moreover, it is often desirable to administer medication in the vagina or other internal areas of the body such as the mouth, rectum, nose, ear and eye. In the case of the vagina, medication can be administered, either in conjunction with use of a contraceptive device or separately. In the treatment of vaginal disorders, it is often desirable that the medication be applied throughout the areas of the vaginal tract and cervix over an extended period of time, for example, several hours or days. The remoter areas of the vaginal tract might not be readily reached by conventional vaginal suppositories due to the compact size and shape required for convenience of insertion. Also, because of the structure and shape of the vagina, inserted suppositories or tablets often do not stay in place, or, upon melting, the medication may drain out of the vaginal passage, thereby reducing the effectiveness of the applied medication. Medicated tampons also do not extend far enough or widely enough into the vaginal tract to deliver medication throughout the vaginal tract. Other types of rigid applicators have similar delivery problems and are uncomfortable to insert and use. Thus, under current methods, the desired medication may not be applied or maintained effectively in the vaginal tract for a sufficient period of time.
A recent commercial product is a contraceptive film sold under the name "VCF"0 by Apothecus, Inc., of Great Neck, N.Y. The VCF film is made of polyvinyl alcohol (PVA) and contains the spermicide called "Nonoxynol-9" and glycerine as a plasticizer material. However, the VCF film does not dissolve readily, and has poor stability in hot, humid environments. The texture of the film is relatively hard, and the film has a sharp edge. The film also delivers only 65 mg. of spermicide, which may be insufficient. It is also expensive to make and unlike a preferred embodiment of the present invention as illustrated in FIG. 3 infra, it has no capacity to be used as a barrier contraceptive.
More importantly, the VCF product suffers from deficiencies of all like prior art products in that it does not dissolve readily and in addition is not stable to prolonged storage at high temperature and high humidity, such as is generally encountered in numerous tropical third world countries as well as seasonally in more temperate climates. Such products become, under exposure to adverse humidity conditions, sticky and excessively hygroscopic. To resolve this problem, prior art devices, as typified by the VCF device, employ expensive protective packaging, such as foil-packs and the like. Such packaging greatly increases the cost of the product to the end user. The high cost discourages use in areas of the world where the product is most needed. Moreover, foil packaging increases package components and since the foils used are not readily decomposable in landfills, such packages have a disadvantaged environmental impact.
It should be noted that as used herein, high temperature means up to 140.degree. F., high humidity means up to 99% relative humidity and prolonged storage means in excess of three years.